MAUDE Adverse Event Report: Ventana Medical Systems Inc. BenchMark ULTRA system; slide stainer, automated

Model Number	BenchMark ULTRA
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a staining run issue with the benchmark ultra system.It was reported that there was a misalignment between the reagent carousel position and what was displayed in the software.The staining appear impacted as they are all a single color with no major staining.
Additional Manufacturer Narrative
The investigation is ongoing.

• Brand Name: BenchMark ULTRA system
• Common Device Name: slide stainer, automated
• Manufacturer (Section D): Ventana Medical Systems Inc.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer (Section G): Ventana Medical Systems Inc.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; +1(925)353-4412
• MDR Report Key: 50870601
• Report Number: 2028492-2026-03911
• Device Sequence Number: 18486681
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BenchMark ULTRA
• Device Catalogue Number: 05342716001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown